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Magazine

Process Improvement

Vaccines

Streamlining Postapproval Submissions Using ICH Q12 & SCDM

ISPE

AUGUST 29, 2022

Following approval of an initial marketing application, postapproval changes are needed to ensure adequate supply, mitigate supply risk, expand patient market access, optimize manufacturing processes, improve analytical methods, and comply with new regulatory expectations. Regulatory. Unlock Access to Member-Only Content.

Documentation

Documentation FDA Communication Packaging

Regulatory Landscape for Raw Materials: CMC Considerations

ISPE

AUGUST 30, 2022

During the pandemic, the pharmaceutical industry faced challenges in the production of COVID-19 therapeutics and vaccines to meet global demand, as well as mitigation of drug shortages for non-COVID-19-related products, without compromising product quality or patient safety. Unlock Access to Member-Only Content. Company Name.

Documentation

Documentation FDA Packaging Communication

Pharmacy Technician Pulse

Streamlining Postapproval Submissions Using ICH Q12 & SCDM

Regulatory Landscape for Raw Materials: CMC Considerations

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